Solvonis Therapeutics PLC (LSE:SVNS), a biotech firm focused on mental health treatments, has shared promising news about AWKN-002, a drug being developed for alcohol use disorder (AUD).
Following what's called a pre-IND meeting last month, the US Food and Drug Administration (FDA) has confirmed that AWKN-002 can move straight into a phase IIb clinical trial without needing extra clinical data.
AWKN-002 is an oral thin film formulation of esketamine, designed for sublingual and buccal administration, combined with structured alcohol education. Solvonis plans to acquire Awakn Life Sciences, the company behind this innovative treatment.
The FDA has also endorsed the use of the 505(b)(2) New Drug Application pathway, allowing existing data from approved esketamine products to support AWKN-002's development. This regulatory route is expected to speed up the process and get the treatment to market faster.
CEO Anthony Tennyson said: "The FDA's support for Awakn's development strategy, particularly their confirmation that AWKN-002 can proceed to phase IIb once a suitable scientific bridge to the product has been established. This marks a significant milestone for Awakn and by extension Solvonis."
Solvonis is currently in the process of acquiring Canada-listed Awakn, with the process expected to complete at some point in the first half.